The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

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Brief Title

The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

Official Title

The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy

Brief Summary

      To determine changes in retinal and choroidal capillaries with optical coherence tomographic
      angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous
      chorioretinopathy (CSC).
    

Detailed Description

      PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of
      studies have reported choriocapillary damage and choroidal vascular remodeling after PDT.
      More recently, although OCTA related CSC research has been conducted, no quantitative report
      has thoroughly investigated the microstructural changes in the superficial, deep retinal and
      choroidal capillaries after hd-PDT. The purpose of the present study is to determine the
      changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in
      eyes with CSC.

      This is a prospective observational study of patients undergoing hd-PDT for CSC with active
      leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein
      angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best
      corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography
      (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue,
      Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each
      follow-up visit after hd-PDT.
    


Study Type

Observational


Primary Outcome

Changes of retinal capillaries after hd-PDT

Secondary Outcome

 The proportion of eyes with complete absorption of subretinal fluid(SRF)

Condition

Central Serous Chorioretinopathy

Intervention

Half-dose photodynamic therapy

Study Arms / Comparison Groups

 CSC patients
Description:  Half-dose photodynamic therapy was performed when a serous retinal detachment involving the macular fovea was present; The treatment field size was set as 3000 microns. This was achieved by administering 3mg/m² of Verteporfin intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the GLD was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². OCTA (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

October 31, 2016

Completion Date

June 30, 2019

Primary Completion Date

October 10, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular
             fovea with SRF confirmed by OCT

          2. Patient age ≥18 years

          3. BCVA ≥35 letters on ETDRS charts

          4. Persistent CSC for a period of time or patients were anxiety about the symptom and
             asking for treatment

          5. Lack of either spontaneous improvement or improvement induced by empirical treatment
             such as pharmaceutical drug

          6. The provision of written informed consent -

        Exclusion Criteria:

          1. The presence of any other chorioretinal diseases that may affect the studies, such as
             age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)

          2. Patients who had received any previous treatment, including PDT, intraocular drug
             injection or focal thermal laser photocoagulation for CSC

          3. Patients with PED in macular fovea which the average diameter (transverse diameter and
             vertical diameter) was more than 300 microns

          4. Patients with high myopia, defined as a refractive error (spherical equivalent) <
             -6.00 diopters, or an axial length >26.5 mm

          5. Patients with media opacities, or signal strength index of the images < 60

          6. Patients under corticosteroid therapy -
      

Gender

All

Ages

18 Years - 65 Years


Contacts

Chenjin Jin, 15521250400, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03692169

Organization ID

CSC-PDT-OCTA(ZOC)


Responsible Party

Sponsor-Investigator

Study Sponsor

Jin Chen-jin


Study Sponsor

Chenjin Jin, Study Director, Zhongshan Ophthalmic Center, Sun Yat-sen University


Verification Date

September 2018